岗位职责和要求
1. Based on Pharma regulations and technical guidelines, be responsible for Marketing Authorization for drugs.
2. Collecting, updating various kinds of laws and regulations information, which are related to our products and Industry, and providing to RA Director / liner manager as useful and valid reference.
3. After establishing new products’ registration / changing registration for existing products, work out registration schedule and action-plan.
4. Finishing all registration dossiers preparation and generation (including docs searching, collection, translation, editing, integrating) and archiving. Submitting registration dossiers to authority on time and following related technical and administrative evaluation progress and answering all questions from Gov’t.
5. Based on laws and regulation requirements, work out and/or adjust relevant internal SOPs, to ensure all regulatory dossiers are fully in line with related laws and regulations.
6. Cooperating with PD, QA/QC and the 3rd party, to optimize and finalize standard research and standard establishment, furthermore, to check and confirm those finalized standard, together with their analytical/testing methods, can be implemented in future commercial production.
7. Based on SOPs, collaborating with PD, Sourcing, QA/QC, to check and confirm all raw materials (including their names, standards and suppliers, etc.) not only can fully meet relevant regulations, but also are exactly same as what are submitted and approved by authority.
8. Based on Pharma Regulation and pharmacopeia, collaborating RD/PD to develop and conduct long-term / accelerate stability studies and other technical studies, so as to meet registration purposes.
9. Responsible for CVM system review work to ensure they are fully compliant from regulation viewpoint.
10. Fully understanding relevant pharma laws/regulations, and collecting Industry information (including technology, national standard, analysis method and raw material, etc.). Adjusting and updating our pharma’s registered standards, accordingly.
11. Be responsible for relevant regulatory stakeholders’ management and maintenance.
